Friday, July 10, 2026

Drug profile · INN

nilotinib hydrochloride dihydrate

nilotinib hydrochloride dihydrate (NILOTINIB HYDROCHLORIDE DIHYDRATE) is an FDA-listed pharmaceutical active ingredient. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 0
News articles 0
Drug details — nilotinib hydrochloride dihydrate
US status
approved
Class
Route
Patents
0
Programs
0
Data quality
0.81

Quick answer

nilotinib hydrochloride dihydrate (NILOTINIB HYDROCHLORIDE DIHYDRATE) is an FDA-listed pharmaceutical active ingredient. Current US regulatory status: approved.

Key facts

INN nilotinib hydrochloride dihydrate
Brand NILOTINIB HYDROCHLORIDE DIHYDRATE
Formulation CAPSULE

Approval history

Authority Status Date
FDA approved

Frequently asked questions

What is nilotinib hydrochloride dihydrate?

nilotinib hydrochloride dihydrate (NILOTINIB HYDROCHLORIDE DIHYDRATE) is an FDA-listed pharmaceutical active ingredient. Current US regulatory status: approved.

What is the brand name for nilotinib hydrochloride dihydrate?

NILOTINIB HYDROCHLORIDE DIHYDRATE is a marketed brand name for nilotinib hydrochloride dihydrate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of nilotinib hydrochloride dihydrate?

nilotinib hydrochloride dihydrate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.